Safety and Tolerability Study of Cerdulatinib Gel, 0.37% in Adults With Vitiligo

Phase 2

Completed

• Conditions: Vitiligo
• Interventions: Drug: Cerdulatinib 0.37% gel; Drug: Vehicle gel

• Registration Number: NCT04103060
• Lead Sponsor: Dermavant Sciences GmbH

Brief Summary

This is a phase 2a, randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, and systemic exposure of cerdulatinib gel, 0.37% in adults with vitiligo

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-25
• Study Start: 2019-09-27
• Status Verified: 2020-11
• Primary Completion: 2020-11-03
• Study Completion: 2020-11-03
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Male and female subjects age 18 and older with a confirmed clinical diagnosis of vitiligo for at least 3 months, including ≥0.5% to ≤30% BSA involvement.
• Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
• Capable of giving informed consent

Exclusion Criteria

• Diagnosis of segmental vitiligo
• Subjects with concurrent conditions or history of other diseases (e.g., current or chronic history of liver disease) that could affect the safety of the subject or the implementation of this study
• Use of any prohibited medication within the indicated period before the first dose of study drug
• Pregnant or lactating females
• Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 8 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's vitiligo
• The subject has received an investigational product within the following time period prior to the first dosing day: 4 weeks or 5 half-lives (whichever is longer).
• Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory test value abnormality that will affect the health of the subject or interfere with interpretation of the results
• History of sensitivity to the study drug, or components thereof or a history of drug or other allergy that contraindicates the subject's participation in the study;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cerdulatinib 0.37% gel	Cerdulatinib 0.37% gel	Cerdulatinib 0.37% gel applied topically twice daily
Vehicle gel	Vehicle gel	Vehicle gel applied topically twice daily

Primary Outcome Measures

Name	Time	Method
Laboratory Values	Baseline through Week 7	Clinically significant abnormal lab values
Adverse Events	Baseline through Week 7	Frequency, severity, and duration of adverse events
Vital signs	Baseline through Week 7	Body temperature, blood pressure, pulse (heart rate), and breathing rate (respiratory rate)
Local Tolerability Scale Score	Baseline, Week 2, Week 4, Week 6, and Week 7	Assessment of local site investigational product administration

Secondary Outcome Measures

Name	Time	Method
Concentration of cerdulatinib	Days 1, 15, 29 and 43	Plasma concentration
Blister fluid biomarker concentration	Baseline and Week 6	From active treated lesions and untreated nonlesional skin

Trial Locations

Locations (1)

Dermavant Investigational Site; 🇺🇸 Worcester, Massachusetts, United States